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injections (20 mg/kg) in 18-mo-old CB6F1 male and female mice, to carefully characterize the safety and efficacy of chronic IGF-1R modulation in aging animals

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Appropriate interventions for treatment of hyperammonemia should be initiated, and such patients should undergo investigation for underlying urea cycle disorders [see Contraindications (4) and Warnings and Precautions (5.6, 5.10)]